Mithra claims its intra vaginal hormonal contraceptive delivery device – known as Myring – is similar in design to the NuvaRring from Merck & Co. (MSD), which generated $732 million in annual sales in 2015.
Nuvaring is a non-biocompatible, flexible ring-shaped device made of transparent ethylene-vinyl-acetate. This polymer matrix gradually releases a combined hormonal contraceptive formulation of etonogestrel and ethinyl estradiol over a 3-week period.
Intra vaginal delivery of birth-control medication has been shown to improve compliance and is generally well tolerated compared to oral or intradermal formulations.
Therefore, since Merck’s patent for NuvaRing device doesn’t expire until April 2018, others have tried to come up with alternative designs.
However, Mithra’s claim is supported by two recently completed studies of 42 patients in the US and EU, both of which state the Myring is a bioequivalent to the NuvaRing.
“The [study] results confirm the bioequivalence [of Myring] to the current market leader, and will be an important part of the regulatory filing for Myring in Europe as well as other markets,” said Valérie Gordenne, CSO of Mithra.
“We are on track to submit Myring for regulatory approval in both Europe and the U.S. in the second quarter of 2017,” she added, with manufacturing to take place at Mithra CDMO.
As a spin-out from the University of Liège, Belgium, Mithra brands itself as a women’s health firm with an integrated R&D contract development and manufacturing (CDMO) platform.
The independent CDMO will comprise of three units and 15,000 sq metres of non-GMP and cGMP production spaces, with Phase I of the construction having been completed in Autumn last year.
The first unit in the new facility specialises in manufacturing of polymeric forms for slow release of a broad range of APIs, with an annual maximal capacity of up to 5 million units.
Additionally, Mithra CDMO offers manufacturing services for sterile injectables, including for non-hormone APIs.
On completion of Phase 2 of the construction, in 2019 Mithra CDMO will also extend its services to tablets.
François Fornieri, CEO of Mithra said “There are very few pharmaceutical players in the world capable of producing as many forms of polymers with the qualifications our CDMO will have,” at the Phase I inauguration in September [Translated].
"Mithra CDMO operates as a pharmaceutical ecosystem where third parties can partner," Jean-Manuel Fontaine, spokesperson for Mithra, told Outsourcing-Pharma.
And although the platform is "dedicated to [Mithra's own] R&D, it is also open to academia/industry who would like to leverage our capacity in drug development from proof-of-concept to market."